SAE DATA a RECONCILIATION
What’s your approach?
Thursday May 22nd, 2008
| 10.15 | Coffee/tea |
| 10.45 | Welcome Anja Heukels, PSDM board member portfolio Data Management |
| 11.00 | SAE Reconciliation: Determining how much to reconcile, then and now at a small biotech Jennifer Juntado, Intermune, Inc., Brisbane, CA, USA 17479_20080522_SAE_Recon_JJ |
| 11.30 | SAE Reconciliation: How to handle ‘a waterfall’ of SAEs? Albert Hage, Astellas, Leiderdorp, The Netherlands 17472_20080522_SAE_Recon_AH |
| 12.00 | New Approaches to SAE Reconciliation for Paper and EDC Studies: A Collaborative Perspective Shannon Labout, CSS Informatics, Cambridge, MA, USA 17480_20080522_SAE_Recon_SL |
| 12.30- 13.30 | Lunch |
| 13.30 | Handling and reconciliation of SAE data: a CRO perspective Gerald Ruiter, IATEC, Amsterdam, The Netherlands 17478_20080522_SAE_Recon_GR |
| 14.00 | SAE data entry: Clinical versus Pharmacovigilance standards Daniel Becker, Solvay Pharmaceuticals, Hannover, Germany 17477_20080522_SAE_Recon_DB |
| 14.30 | Coffee/Tea |
| 14.45 | What’s your approach? |
| 15.15 | Plenary discussion Shannon Labout, Albert Hage, Gerald Ruiter, Jennifer Juntado, Daniel Becker |
| 16.00 | Closure and drinks |
hosted by Solvay Pharmaceuticals, Weesp
Pharmaceutical Statistics and Data Management 